Primary OsteoarthritisPost-Traumatic ArthritisInflammatory Joint DiseaseFemoral Neck FractureFemoral Head NecrosisSequelae From Previous Hip SurgeryOsteotomiesCongenital Hip Dysplasia
Investigational drug(s) / intervention(s)
Avantage Reload cup
Avantage Reload cup: Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Study summary
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically
* Primary osteoarthritis
* Post-Traumatic arthritis
* Inflammatory joint disease (e.g. Rheumatoid arthritis)
* Femoral neck fracture
* Femoral head necrosis
* Sequelae from previous hip surgery, osteotomies, etc.
* Congenital hip dysplasia
Additional inclusion criteria include:
* Male or female
* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understand study information and give written consent (specific local regulatory requirements)
Exclusion Criteria:
* Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®
RELOAD:
Absolute contraindications include:
* Infection
* Sepsis
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality
Additional contraindications include:
* Subjects unable to co-operate with and complete the study
* Dementia and inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision
Primary outcome measure(s)
Survivorship — 10 years post-surgery Implant survivorship
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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